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Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer

Study acronym: DESTINY-Lung06
StatusRecruiting
PhasePhase 3
Started2025-10-24
View on ClinicalTrials.gov ↗

Amendment history

2026-09-16
Trial sites expanded: 237 → 242 locations
2026-07-17
Study Status, Contacts/Locations v6
Trial sites expanded: 160 → 237 locations
2026-06-30
Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v5
Trial sites expanded: 100 → 160 locations
Primary completion pushed: 2030-03-05 → 2030-04-24
Completion pushed: 2032-07-05 → 2032-11-24
InterventionsChemotherapy (Drug), Pemetrexed (Drug), Trastuzumab Deruxtecan (Drug), pembrolizumab (Drug)→Pemetrexed (Drug), Platinum Chemotherapy (Drug), Trastuzumab Deruxtecan (Drug), pembrolizumab (Drug)
Eligibility criteria+423 characters
[...] es. Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure, and the Pregnant Partner I [...] tee on Cancer, Eighth Edition). Has no known AGAs (based on existing test result ofthe local test results obtained using validated or approved tests as required per local regulation) that have locally available therapies targeting their AGAs [...] e). Note: Participants with mixed histology are eligible if adenocarcinomanon-squamous NSCLC is the predominant histology. Mixed tumors will be classifi [...] n at least 6 months before the date of the first trial dose andif shouldtheir [...]
Secondary endpointsdetails revised at 1 of 1 entry
2026-01-06
Study Status, Contacts/Locations v4
Study sites74→100
2025-12-02
Study Status, Contacts/Locations v3
Start dateestimated 2025-10-07→confirmed 2025-10-24
Study sites26→74
Show 2 earlier versions
2025-09-16
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2025-09-07→2025-10-07
Study sites0→26
2025-05-02
Study Identification, Study Status, Arms and Interventions v1
Study title-40 characters
Study of Trastuzumab Deruxtecan in Combination With, Pembrolizumab, Versus Pembrolizumab Withand Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer
2025-03-21
Original filing
This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.
Trial Details
NCT Number NCT06899126
Lead Sponsor Daiichi Sankyo
Collaborators: Merck Sharp & Dohme LLC
Conditions Non-small Cell Lung Cancer
Enrollment 686 participants
Start Date 2025-10-24
Primary Completion 2030-04-24 (estimated)
Study Completion 2032-11-24 (estimated)
Updated on ClinicalTrials.gov 2026-09-15